judgmentalist
Registered
Okay, so just for shits and giggles I've been researching what it would actually take to comply with FDA standards for producing sterile medicine. This is of course just a thought experiment with no correlation whatsoever to anything that might or might not happen in the real world. For entertainment purposes only etc., etc.
Short version:
ISO X basically refers to how many times an hour the air is filtered through HEPA filters in order to produce an air particle count of no more than Y. I believe ISO 9 is like "kitchen" and ISO 1 is basically insane.
You would have to have an ISO 8 "gowning room" which essentially corresponds to pretty clean office environment - where you cover up from head to toe in clean room work clothes - which then leads into an ISO 7 work space room.
Inside the ISO 7 work space you would then have a Laminar Flow Hood work area which would technically bring your area in which the sterile meds are produced up at least one more level to ISO 6 or so.
In addition to these basic air particle count requirements there is an entire handbook full of other requirements to meet any particular ISO X level designation. Construction materials, cleaning processes, etc. etc. etc.
Now no UGL as we think of them is capable of creating this type of environment, and even if they were capable of it financially, and were inclined to do so, assembling and powering all the equipment involved would almost certainly draw unwanted attention, similar to the way the power company can alert our bacon-scented besties if they see an unusual spike in power usage that might indicate some stoner kid wants to be the next https://en.wikipedia.org/wiki/Jimmy_Cournoyer .
Having said that, it is obviously possible to create sterile-enough product judging by the fact that in the imaginary world in which this thought experiment takes place people use gear created by UGLs every day and mostly don't die. The producers do their best to create as sterile an environment as they can (the good ones, at least) and the disinfectant material used in the production process creates a very hostile environment for anything to grow in anyway.
Having said that, the regulations are in place for a reason.
I'm curious if anyone else finds this interesting. What do you think about the clean room regs? Do you think they are ultimately unnecessary? If so, why are they in place? If it were consistently possible to produce sterile medicine in an unsterile environment and then simply filter it and kill any potential pathogens present, then why isn't Pfizer allowed to do it that way?
Are you aware of anything I am describing inaccurately? What am I missing? Do you think this is all a load of crap and I should just post pictures of girls with their asses hanging out?
Short version:
ISO X basically refers to how many times an hour the air is filtered through HEPA filters in order to produce an air particle count of no more than Y. I believe ISO 9 is like "kitchen" and ISO 1 is basically insane.
You would have to have an ISO 8 "gowning room" which essentially corresponds to pretty clean office environment - where you cover up from head to toe in clean room work clothes - which then leads into an ISO 7 work space room.
Inside the ISO 7 work space you would then have a Laminar Flow Hood work area which would technically bring your area in which the sterile meds are produced up at least one more level to ISO 6 or so.
In addition to these basic air particle count requirements there is an entire handbook full of other requirements to meet any particular ISO X level designation. Construction materials, cleaning processes, etc. etc. etc.
Now no UGL as we think of them is capable of creating this type of environment, and even if they were capable of it financially, and were inclined to do so, assembling and powering all the equipment involved would almost certainly draw unwanted attention, similar to the way the power company can alert our bacon-scented besties if they see an unusual spike in power usage that might indicate some stoner kid wants to be the next https://en.wikipedia.org/wiki/Jimmy_Cournoyer .
Having said that, it is obviously possible to create sterile-enough product judging by the fact that in the imaginary world in which this thought experiment takes place people use gear created by UGLs every day and mostly don't die. The producers do their best to create as sterile an environment as they can (the good ones, at least) and the disinfectant material used in the production process creates a very hostile environment for anything to grow in anyway.
Having said that, the regulations are in place for a reason.
I'm curious if anyone else finds this interesting. What do you think about the clean room regs? Do you think they are ultimately unnecessary? If so, why are they in place? If it were consistently possible to produce sterile medicine in an unsterile environment and then simply filter it and kill any potential pathogens present, then why isn't Pfizer allowed to do it that way?
Are you aware of anything I am describing inaccurately? What am I missing? Do you think this is all a load of crap and I should just post pictures of girls with their asses hanging out?